Hypothesis / aims of study
The natural history of overactive bladder (OAB) and other lower urinary tract symptoms (LUTS) in women with pelvic organ prolapse (POP), both treated and untreated, is not well characterized. Women seeking care for bothersome LUTS at six tertiary centers were enrolled in an observational study and assessed a wide range of LUTS using the LUTS Tool at baseline, 3 months and 12 months. Our aims were to (1) determine baseline association between LUTS Tool scores and POP and (2) compare change in LUTS Tool scores from baseline to 12-months in women with and without POP. We hypothesized that the LUTS Tool scores would be associated with the presence of POP and that LUTS Tool responses are stable over time in patients with and without POP at baseline.
Study design, materials and methods
Women enrolled in a large observational cohort study of patients seeking care for bothersome LUTS were eligible. Those with missing LUTS Tool data or incomplete/inconsistent Pelvic Organ Prolapse Quantification (POP-Q) data were excluded. The presence of prolapse (yes/no) was identified at baseline if maximum vaginal descent (MVD: greatest of POP-Q points Ba, Bp or C) was >0. Participants who had POP surgery or pessary treatment between baseline and follow-up visits were considered treated. Primary outcomes included LUTS Tool scales (OAB, obstructive, stress incontinence; all scaled 0-100), LUTS Tool Severity and change in LUTS Tool scores from baseline to 12-months. For each scale, repeated measures (within subject) linear regression models were fit with scale as the outcome and prolapse group, age, body mass index, a comorbidity index, smoking status, diabetes, hysterectomy, baseline LUTS scale score, and LUTS treatment included as fixed-effect predictors. The study was designed to achieve >90% statistical power to detect differences as small as 0.4 standard deviations for less prevalent group comparisons such as those with prolapse versus not.
Results
371 women were included; 311 (84%) without and 60 (16%) with prolapse at baseline. Of those with prolapse, 36 (60%) were treated during follow-up. Those with prolapse were significantly older (64.6±8.7 vs. 55.3±14.1, p<.001), and less likely to be Black (2% vs. 15%, p=0.006). During follow-up, women with prolapse (vs. without) reported greater Kegel exercise (57% vs. 41%, p=0.034) and less OAB medication (12% vs. 28%, p=0.013) use. Other baseline factors and LUTS treatments (physical therapy, sling, onabotulinumtoxinA and neuromodulation) during follow-up did not differ by prolapse status. Figure 1 shows LUTS Tool scores over time by prolapse group. In multivariable models, interaction terms between prolapse groups and visits were not significant (all p>0.05). All LUTS Tool scores decreased at 3- and 12-month visits (mean changes ranged from -4.44 to -14.29, all p<0.001), but scores did not differ between prolapse groups.
Interpretation of results
LUTS Tool scores (OAB, obstructive, stress incontinence and total severity) were not associated with presence of POP. LUTS Tool scores decreased similarly over 12 months in patients with and without POP.